ЛІОФІЛІЗАЦІЯ У НАНОМЕДИЦИНІ: РОЗРОБКА ПРОЦЕСІВ, КОНТРОЛЬ ЯКОСТІ ТА ВПРОВАДЖЕННЯ ПРИНЦИПІВ QbD
Ключові слова:
lyophilization, biopharmaceuticals, nanomedicine, Quality by Design, quality control, lyoprotectantsАнотація
The study examines lyophilization as a method for stabilizing biopharmaceuticals and nanostructured systems. Main process stages and critical quality parameters are analyzed. The importance of Quality by Design and lyoprotectants for reproducibility, structural integrity, and biological activity is highlighted.
Посилання
A Comprehensive Review of the Latest Trends in Spray Freeze Drying and Comparative Insights with Conventional Technologies / M. Ioannou Sartzi et al. Pharmaceutics. 2024. Vol. 16, No. 12. P. 1533. https://doi.org/10.3390/pharmaceutics16121533
Ahammad S. R., Narayanasamy D. A QbD approach for optimizing the lyophilization parameters of cyclophosphamide monohydrate. Drug Development and Industrial Pharmacy. 2025. P. 1–11. https://doi.org/10.1080/03639045.2025.2487615
Gatto M. S., Najahi-Missaoui W. Lyophilization of Nanoparticles, Does It Really Work? Overview of the Current Status and Challenges. International Journal of Molecular Sciences. 2023. Vol. 24, No. 18. P. 14041. https://doi.org/10.3390/ijms241814041
Process development and quality attributes for the freeze-drying process in pharmaceuticals, biopharmaceuticals and nanomedicine delivery: a state-of-the-art review / S. R. Pardeshi et al. Future Journal of Pharmaceutical Sciences. 2023. Vol. 9, No. 1. https://doi.org/10.1186/s43094-023-00551-8
Atre P., Rizvi S. A. A. Advancements in Pharmaceutical Lyophilization: Integrating QbD, AI, and Novel Formulation Strategies for Next-Generation Biopharmaceuticals. Biologics. 2025. Vol. 5, No. 4. P. 35. https://doi.org/10.3390/biologics5040035